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Puma Biotechnology, Inc., a biopharmaceutical company, focuses on the acquisition, development and commercialization of products to enhance cancer care.
Product Candidates
PB272 (neratinib (oral))—Breast Cancer: Neratinib is a potent irreversible tyrosine kinase inhibitor (TKI), that blocks signal transduction through the epidermal growth factor receptors, HER1, human epidermal growth factor receptor type 2, and HER4. Neratinib has clinical application in the treatment of various cancers, including breast cancer, non-small cell lung cancer and other tumor types that over-express or have a mutation in human epidermal growth factor receptor type 2.
PB272 (neratinib (intravenous))—Breast Cancer: The company also intends to develop neratinib as an intravenously administered agent. In pre-clinical studies, the intravenous version of neratinib resulted in higher exposure levels of neratinib in pre-clinical models. The company is evaluating the intravenous formulation of neratinib and considering options relative to its development in 2015.
PB357: PB357 is an orally administered agent that is an irreversible TKI that blocks signal transduction through the epidermal growth factor receptors, HER1, human epidermal growth factor receptor type 2 and HER4. PB357 is structurally similar to PB272. Pfizer Inc. had completed single dose Phase I trials of PB357. The company is evaluating PB357 and considering options relative to its development in 2015.
PB272 (neratinib (oral))—Other Potential Applications: In September 2014, the company reported initial data from the ongoing, open label Phase II clinical trial of PB272 (neratinib) for the treatment of patients with non-small cell lung cancer, with human epidermal growth factor receptor type 2 mutations as a late-breaking oral presentation at the European Society for Medical Oncology 2014 Congress.
In 2013, the company announced that the company had initiated a Phase II clinical trial of neratinib as a single agent in patients with solid tumors that have an activating human epidermal growth factor receptor type 2 mutation (basket trial).
In 2014, the company announced that the company expanded the first cohort from the Phase II clinical trial of PB272 in patients with solid tumors who have an activating human epidermal growth factor receptor type 2 mutation (basket trial).
Strategy
The company’s strategy is to become a leading oncology-focused biopharmaceutical company. The key elements of the company’s strategy include advancing PB272 (neratinib (oral)), its lead drug candidate, toward regulatory approval and commercialization; expanding its product pipeline by pursuing additional applications of neratinib; focusing on developing innovative cancer therapies; building a sustainable pipeline by employing multiple therapeutic approaches and disciplined decision criteria based on clearly defined proof of principal goals; and evaluating the commercialization strategies on a product-by-product basis to maximize the value of each.
Intellectual Property and License Agreements
The company holds a worldwide exclusive license under its license agreement with Pfizer to four granted U.S. patents and nine pending U.S. patent applications, as well as foreign counterparts thereof, and other patent applications and patents claiming priority therefrom.
In the United States, the company has a license to an issued patent, which would expire in 2025, for the composition of matter of neratinib, its lead compound. The company has a license to an issued U.S. patent covering a family of compounds, including neratinib, as well as equivalent patents in the European Union and Japan, that expire in 2019.
The company also has a license to an issued U.S. patent for the use of neratinib in the treatment of breast cancer, which expires in 2025, and an issued U.S. polymorph patent for neratinib, which expires in 2028.
Research and Development Expenses
Research and development activities, which include personnel costs, research supplies, clinical and pre-clinical study costs, are the primary source of the company’s overall expenses. Such expenses related to the research and development of the company’s product candidates totaled $122.9 million for the year ended December 31, 2014.
Government Regulation
The company’s drug product candidates are marketed in the United States after the drug has received the U.S. Food and Drug Administration approval.
History
Puma Biotechnology, Inc. was founded in 2010.

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